Gabriella Sonaglia

· Short-term contract position for a large device trial

· Conduct virtual screening and device setup visits

· Ensure participant compliance and quality data collection

· Resolve device troubleshooting issues

· Resolve EDC queries

• Plays vital role in planning and coordinating all research projects, i.e. mandating training, communicating with CRO’s, sponsors, regulatory team to ensure all aspects are well prepared.
• Led a team of 13 clinical research coordinators, providing mentorship, training, and performance management to ensure high-quality and efficient trial execution.
• Supervising and coordinating the activities of the clinical research team, which include research nurses, coordinators, and other support staff. This involves scheduling, training, and ensuring adherence to standard operating procedures (SOPs).
• Manage 42 clinical unit bed plan for in-house participants.
• Planning and preparing advertising and marketing strategies to increase outreach for recruitment and improve retention.
• Responsible for all start up and close out procedures.

• Lead coordinator for The Michael J. Fox Foundation (MJFF), Parkinson’s Progression Markers Initiative (PPMI) 2.0 to identify and validate biomarkers of Parkinson’s disease (PD).
• Lead coordinator for a Phase 2 double blind trial, IKT-148009, Inhibikase Therapeutics, to help slow the progression of Parkinson’s Disease.
• Lead coordinator for AbbVie, Open-Label Extension of Studies M15-736 and M20-339 to Evaluate the Safety and Tolerability of 24-Hour Daily Exposure of ABBV-951 in Subjects With Advanced Parkinson’s Disease.
• Create, maintain, and organize documents such as sponsor compliant eCRFS and source documents.
• Coordinate day-to-day activities of all research related activities, carrying out the protocol as appropriate to the position; scheduling, conducting patient visits, and entering data.
• Responsible for organizing and preparing for both internal and external auditing and monitoring visits as needed.

• Managed clinical trial protocols, patient recruitment, and data collection for multiple clinical research projects.
• Managed recruitment and retention of study participants and organized events for recruitment.
• Collect, process, and ship research biospecimens.
• Preparing site for upcoming studies as well as keeping track of pertinent clinical trial information from start up to site activation.
• Ensuring the protocol is being followed accurately.